Background
A person’s mental state represents their cognitive and behavioural state and includes factors such as physical health, appearance, emotional state, thought patterns, sensory awareness, orientation, memory, interpretation ability and motor activity.1 2 Indicators of mental state include mood, behaviour, cognition, judgement, memory, thought process and content, insight and judgement.2 Mental state deterioration (MSD) is exacerbated by poor mental health, cognitive impairment and physical health conditions, including delirium, atypical responses to prescribed treatments or intoxication with licit or illicit substances.3 Extrinsic factors like ‘locked doors’ policy, waiting times, clinical practices such as restrictive interventions, specific characteristics of the staff–patient relationship that lead to limit setting, practices around patient and visitor movements, and service expectations are factors that impact MSD.4–6
Previously implemented changes to address and manage MSD in healthcare settings included Code Grey and Code Black standards (a multidisciplinary team response to aggressive behaviour incidents).3 Code Grey is a coordinated clinical and security response across the hospital to actual or potential patient or visitor aggression and violence towards others, which creates a risk to health and safety.7 On the contrary, Code Black is a response to actual or potential aggression or violence involving a weapon (armed threat).8 These standards were introduced in the Victorian healthcare system to promote consistency in responding to occupational violence and aggression incidents.7
There is, however, a continuing trend of MSD occurring in acute hospital settings, which results in poor health outcomes, adverse events and distress for the patient, their families, caregivers and staff.9–11 As an adverse outcome, MSD is also associated with other adverse outcomes such as trauma, clinical aggression and the use of restrictive practices or interventions.12 13 For clinical aggression, the impacts on staff are well documented, including managing unpredictable behaviours, staff injury, sick leave, the effect of perceived risk and emotional distress associated with actual aggression, and the impact on morale, performance and job satisfaction.14–17 The effects on organisations include the cost of sick leave, litigation, decreased staff effectiveness and difficulty recruiting and retaining staff.5 6 18 Organisations are responsible for identifying and implementing interventions to manage and minimise MSD. Moreover, to also provide high-quality care, organisational leaders need to promote a healthy, respectful, safe work environment and employ a skilled, engaged and compassionate workforce.19 The existing body of research around managing clinical aggression in settings such as emergency departments, mental health, and geriatric settings is well established.20–22 However, to date, little attention has been paid on the role of rapid response team in early identification and management of patients presenting with MSD in acute hospital settings. Furthermore, current approaches are inconsistent and MSD rates remain high.3 23 To address this knowledge gap, a tertiary teaching hospital in Melbourne is trialling DIvERT (De-scalation, Intervention, Early, Response, Team) intervention to manage patients presenting with MSD. The proposed synthesis is part of a larger project, a realist evaluation of DIvERT. As an early intervention strategy, DIvERT aims to intervene at the first sign of MSD and mobilise a timely response to ensure that patients receive appropriate and timely care plans and to prevent associated risks from escalating.
Realist reviews
A realist review is a theory-driven methodology to comprehensively review the literature and apply realist philosophy to synthesise findings.24 Realist programme theories articulate the key components of the programme, the intended outcomes, as well as the contexts that may shape the mechanisms through which the programme contributes to those outcomes.25 The objective of a realist review is to test, refine and refute initial programme theories (IPTs) explained through context–mechanism–outcome (CMO) configurations that consolidate evidence from diverse data sources.26 As the first step in the realist cycle, IPTs are a way of initially theorising the intention of an intervention by classifying and organising assumptions of programme designers.27 The realist approach seeks to address the questions, ‘what works, for whom, in what respects, to what extent, in what contexts, and how?’ instead of ‘does it work’.28 29 The methodology is based on the philosophical paradigm of realism, which positions itself between the positivist and the constructivist paradigms and emphasises the search for alignment between reality and our constructions of reality.30 31 To apply the methodology, researchers must examine the underlying mechanisms that explain ‘how’ the outcomes are produced and the influence of context.31 32
This distinctive understanding of generative causation is the hallmark of the realist approach and supports understanding how programmes and policies generate outcomes through human decisions.24 Achieving this requires uncovering the architecture of programmes and services, the formal and informal resources, and efforts alike.33 The driving forces for the construction are retroduction, the search to unearth causal mechanisms (underpinning causal forces) and ontological depth; reality is stratified, and thus causal evidence transpires at a deeper level of reality.33 34 The causal links between CMOs are the fundamental principles of the realist research methodology.35 The CMO framework is generally summarised as context + mechanism = outcome.29 Table 1 provides a brief overview of CMO.
What are C, M and O?
Research based on realist principles involves developing IPTs, and a realist review tests and refines these theories. IPTs are the testable hypotheses about how, for whom and in what circumstances a programme is thought to work and are a fundamental and prerequisite part of the evaluation methodology.36 IPTs evaluate the original intentions of the programme by theorising, classifying and organising the experiences and assumptions of the programme designers and implementers. In contrast to traditional systematic reviews, realist reviews rely on multiple data sources to test theories rather than using only peer-reviewed sources.37 This use of multiple sources is aligned with the concept of theory triangulation which uses different methods to answer the same question.38 Central to theory triangulation is that processes leading to the same results strengthen research findings.39
The Australian healthcare system
The Australian healthcare system is complex, the state funds hospitals’ infrastructure and workforce, while the federal government funds the healthcare system’s Medicare (activity). There are different challenges when improvements are introduced; any changes, policies and initiatives need to align with the State Department of Health objectives. Implementation chains go through various routes, from the intervention designers to the various committees that may have to approve the policy and the ward environment in the hands of staff who might have different competing priorities.40 The realist methodology has been selected because it provides the systematic tools for synthesising complexity and the potential to improve service delivery by focusing on granulated contextual analysis to explain how a programme works.24 31
Methods
The primary stages of a realist review are comparable with those of a standard Cochrane review; however, the substeps involved in completing a realist review may be overlapping and iterative rather than chronological.25 This iteration strengthens the explanation building with primary research examined for its contribution towards IPT development and refinement.31 Figure 1 shows a synopsis of the realist review stages.
Iterative, non-linear process.
Stage 1: preliminary programme theory development
As the first key step in realist methodology, IPTs provide a theoretical framework for articulating the assumptions and ideas underlying how and why an intervention or programme is expected to be effective.25 41 Thus, in this stage, we will broadly theorise our intervention for managing MSD, which should also provide a structure for organising synthesis findings.24 35 41 IPTs are progressively refined, tested and added to as the review progresses to other stages. We will complete a preliminary scoping review through purposeful and iterative searching of the peer-reviewed English language literature on existing interventions to manage MSD in acute hospital settings. The following search terms will be used: ‘mental state deterioration’, ‘behavioural disturbances’, ‘acute behavioural disturbances’, ‘violence prevention’, ‘restraint’ and ‘medical response team’, ‘medical emergency teams’, ‘rapid response team’ from the last 10 years. We will also scope the grey literature to support theory development.
From a tentative scope of the literature for theories, we found sufficient literature to support IPT development. Here is what we think we will find, for a rapid response system to be effective, there needs to be organisational changes at distinct levels and CMO will encompass processes of care, therapeutic practices, and organisational supports.42–44
Processes of care relate to the actions and decisions that healthcare staff will take and make collaboratively to recognise, escalate, manage and report deterioration in mental state safely and effectively.
Therapeutic practices will represent the collaborative approaches that healthcare staff adopt through a rapid response system to manage patients presenting with MSD. Some of the mechanisms that lead to outcomes include timely responding to MSD, teamwork, shared decision making, communication, cultural competence, delivering care pathways that acknowledge and respect people’s experience with trauma, safely avoiding restrictive practices and identifying precursors to incidents and prevent recurrences.
Organisational supports describe the underlying, organisational and governance structures that support the healthcare workforce to effectually recognise and manage patients presenting with MSD. The organisational leadership should allocate resources to support the delivery and effective functioning of the systems for managing MSD.
Overall, there is critical role of the organisational leadership in leading the vision, being proactive, accountable and engaged by availing resources for addressing MSD.44–46 According to reviewed sources, there is consensus that changes should include implementing guidelines and rapid response system policies for the local context, which align with relevant national, state, and local policies.5 43 47
The importance of increasing preparedness is highlighted in the literature through tailored education training programmes for addressing MSD.48 49 Accordingly, training modules should be relevant to the core competencies required by all staff working with patients, including allied health.48 Previous research50 established that staff feel more confident about patients’ medical condition than about cognitive, behavioural challenges and mental health problems. Additionally, staff commented that early involvement of a specialist team would be invaluable in managing patients with complex co-morbidities.50 Overall, there is evidence to indicate that training such as on recognising early signs of agitation potentially improves the confidence and clinical skills of staff leading to improved patient outcomes and MSD interventions that represent safe and cost-effective approaches.46
The composition of the rapid response team should include a mix of skills, involving mental health trained staff, doctors, nurses and medical trainees, each with varying levels of operational oversight.51 Therefore, the optimal functioning of rapid response system depends on understanding of roles and responsibilities, liaison between those who call the response team (users), those rostered to respond (response team members), and the intra-interdisciplinary communication and cooperation. Facilitators of optimal effectiveness can be improved through staff training in leading and managing rapid response calls, including the non-technical team leadership skills, knowledge of deterioration indicators, communication skills and encouraging users to voice any ongoing or unresolved clinical concerns during response calls.52 53
The decision to activate the rapid response system is often moderated by justifying the need by seeking affirmation from peers or gathering more clinical data to avoid unnecessary activation.54 Justification requires increasing competencies such that nursing staff are confident in applying clinical reasoning supported by assessment tools, clinical indicators together with clinical experience.54 It is argued that staff who were unsure whether patient met the rapid response criteria questioned themselves if they were doing the ‘right thing’ and the time spent justifying limits the rapid response as an effective early intervention strategy.53 54 Evidence5 12 18 supports implementing process management features including staff using validated screening and risk assessment tools, as prompts about the importance of early recognition and management of MSD to minimise associated risks from escalating.
Several studies5 13 suggest that there is extensive under-reporting of MSD incidents mainly due to cumbersome reporting systems, lengthy digital forms and staff reluctance to report leading to incident data that is not reliable, comparable and often of poor quality for quality improvement and evaluation purposes. Reporting procedures must be simple and user-friendly and staff should be confident that they will receive management support when they report incidents, reinforcing the importance of feedback and feedforward processes.52 55 From the evidence from our brief scope of the literature, we have developed our tentative working IPTs shown in table 2. As the first step in theory refinement, we hope to test, refine and develop other theories through the proposed synthesis.
Tentative initial programme theories
Stage 2: search for evidence
Stage 2 involves focused and iterative searching based on articulated IPT. Purposive sampling is used to identify specific evidence to test particular hypotheses and to identify primary research studies that will facilitate the refinement of theories.31 There is no finite set of relevant research papers for realist reviews, and the strength-by-numbers approach does not apply. Therefore, a small number of relevant studies on the grounds of rigour does not impact nor reduce the validity and generalisability of synthesis findings.25 33 As highlighted by Saul et al,26 searching for evidence involves four stages, which are summarised as follows;
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A background search to get a feel for the literature.
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Progressive focusing on identifying the programme theories.
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A search for empirical evidence to test a subset of the programme theories.
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A final search once the synthesis is almost complete.
Literature searches will be carried out in the Excerpta Medica database (EMBASE), the Cumulative Index to Nursing and Allied Health Literature (CINAHL) and the Online Medical Literature Analysis and Retrieval System (MEDLINE), supplemented by citation tracking to identify peer-reviewed articles relevant, first, to MSD and, second, to rapid response teams in the context of acute hospital settings. We will also search the grey literature for government framework documents, health policy directives and theory guidance documents. We aim to evaluate primary research and grey literature for evidence that will contribute conceptually and empirically to test, refine and rebuke our IPT.
The inclusion and exclusion criteria will be continuously refined, considering emerging data. The date range coverage will be for evidence published in the last 10 years, and a search strategy is provided in online supplemental appendix. Before the main search, a preliminary search will be conducted to determine whether the topic has already been examined and to check for broadness, narrowness and alternative terminology. As necessary, the search will be refined and may need to be performed several times until there are no spelling errors or missing terms, and the search returns relevant articles. In realist reviews, searching continues in a cyclical and iterative process that is not exhaustive; however, test saturation can be applied at each searching stage by checking whether anything new has been added to the understanding and whether further searching will add new insight.25 31 On completion of the final search, each database search will be saved, and all searches will be exported to the Endnote reference manager. Details of the final search will be documented in a table.
Supplemental material
Stage 3: literature selection and appraisal
After initial screening of titles and abstracts, retained sources will be imported into Covidence for further screening. The full-text articles will be screened further by two members of the research team to improve the reliability, objectivity and quality of the screening process. Any disagreements encountered will be resolved through discussion and consensus during team meetings. In accordance with the realist review methodology, the relevance of evidence is determined by whether the evidence addresses the theory under test. Based on the RAMESES (Realist And Meta-narrative Evidence Syntheses: Evolving Standards), rigour will be evaluated by assessing whether specific inferences drawn have sufficient support to make a methodologically substantial influence when testing IPT.24 25 The appraisal of studies will be based on how specific sections of their evidence support a particular programme theory regarding the links between context, mechanism and outcome.56 In other words, we are interested in selecting studies based on the knowledge they contribute to understanding of the CMO configuration framework. Studies should contribute a different component to the rich picture that constitutes the overall synthesis of evidence.57 In the third stage of screening, sources will read in full and screened in Covidence by two members of the research team with regular feedback of potential sources for consideration to the whole team through our team meetings. We will use the TAPUPAS framework (Transparency, Accuracy, Purposivity, Utility, Propriety, Accessibility and Specificity) during the appraisal process for transparency and to provide a reference for judgements about rigour, richness and relevance to justify the selection of sources.58 Using the Covidence software, we will create a PRISMA (Preferred Reporting Items for Systematic review and Meta-Analysis) flow chart which will be downloaded and modified in Microsoft word to meet our synthesis needs.
Stage 4: data extraction
Since primary studies will use a variety of research methodologies, there is no one-size-fits-all approach when it comes to extraction. Realist reviews assimilate information more by capturing notes and annotation than by extracting data per se.25 We will use Microsoft Excel to create a table of characteristic to organise a summary of key information about literature sources such as the study design, participants, interventions, outcomes and key findings that contribute to our understanding of effective functioning of a rapid response model for managing MSD in acute hospital settings. Additionally, context, mechanism and outcome themes will be extracted and organised using a Microsoft Excel data matrix. Two research team members will complete the extraction of CMO themes which will be discussed and evaluated with the rest of research team in our regular meetings. Based on our review of the literature, which highlighted the role of processes, therapeutic practices and organisational support in thinking about the effectiveness of rapid response teams, we are interested in sources that improve the conceptual richness and contextual thickness of evidence.59 A reviewer is said to change from divergent to convergent thinking during the data extraction phase by switching from CMO framework building to framework testing and from theory construction to theory refinement.24 ,31
Stage 5: synthesis of evidence
Data synthesis refers to the explanatory pursuit that will lead to an understanding of what it is about interventions for addressing MSD that works, for whom, in what circumstances, in what respect and why.25 Since realist reviews begin with theories and conclude with more refined theories, this phase is intended to translate the analysis of data into refined programme theories.60 In other words, it is making sense of the analysed data using the IPTs, which will produce more refined evidence-based theories. Like figuring out a puzzle to form a causal picture, the aim being to re-articulate the evidence guided by the principles of generative causation. That is, an outcome is generated by a related mechanism triggered in a particular context. Data will be coded using three approaches: deductively using ideas from the initial literature search, inductively drawing conclusions from the data in the literature and reproductively inferring potential CMOs from the literature.24
A Microsoft Excel spreadsheet will be used to code the CMOs based on the IPTs. Demi-regularities will be explored and recorded for their causative mechanisms. A demi-regularity is a partial event regularity that indicates a mechanism is occasionally actualised, but not always, over a particular period of time.61 In line with realist synthesis publication standards, a description of the review team and participation in the analysis and synthesis process will be provided in the final review.24
Stage 6: dissemination of the findings
The final phase of a realist synthesis is to present refined theories and engage the key stakeholders through meetings for sense-checking, refinement and to prioritise theories to be tested in future research. We have a delegated governance steering committee overseeing DIvERT at our organisation. The committee had oversight on the DIvERT implementation and regularly meets to discuss progress. The research team met with committee at commencement of realist evaluation via Microsoft Team and there has been ad hoc email communication to meet requests for the evaluation needs. We hope to arrange another team meeting with the DIvERT steering committee to discuss our findings when we complete the synthesis. Through this iterative process of stakeholder review and refinement, programme theories are tested and validated as the steering committee are the subject matter experts.25 62 63 Refined theories should be presented to gain a deeper understanding of how intended and unintended outcomes are achieved through the interaction of mechanisms in given contexts.26 Furthermore, refined theories can assist programme designers in identifying the considerations and caveats that should be considered and to support decisions.
This protocol encapsulates the steps that will be adopted to complete this realist review in line with the RAMESES methodological guidelines for realist reviews.24 The proposed review will serve as a foundation for a realist evaluation of an intervention to improve outcomes for MSD in the acute hospital settings. The construction of IPTs will also contribute to scholarly knowledge on the management of MSD which is currently limited.
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